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AzTrials

Stage IV Colorectal CancerPhase 2ULTRANCT01704703

Study of FOLFIRI + Panitumumab Using Ultra-selection Technology of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques

A Phase 2 study testing panitumumab and FOLFIRI in people with Stage IV Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IV Colorectal Cancer
What is being tested?
panitumumab and FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSpain
Study dates
Oct 2012to Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Competent to understand, sign and date an IEC-approved informed consent form.
  • Men or women 18 years of age or older at the time the written informed consent is obtained.
  • Histologically confirmed metastatic adenocarcinoma of the colon or rectum Wild-Type RAS (No mutation) with at least 1 measurable metastatic lesion following RECIST criteria v 1.1 and initially irresectable (non suitable for radical surgery at the inclusion time).
  • Obtention of DNA from tumor tissue blocks sent to central lab (ICO) that is amenable for highly sensitive techniques
  • Previous irinotecan based chemotherapy +/- bevacizumab for metastatic CCR during at least 6 weeks.
  • Irinotecan based chemotherapy does not need to be the most recent chemotherapy administrated. There are no restrictions on numbers of treatments lines before study inclusion.
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  • Disease progression during irinotecan treatment or within 6 months after irinotecan treatment.
  • Karnofsky status ≥ 70% .
  • Adequate bone marrow, hepatic, renal and metabolic functions,
  • Adequate bone marrow function: neutrophils ≥ 1.5x109/ L; platelets ≥ 100x109/L; hemoglobin ≥ 9g/dL.
  • Hepatic functions as follows: total bilirubin count ≤ 1.5 x ULN; ALAT and ASAT ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastasis).
  • Renal function: creatinine clearance > 50 ml/min (according Cockcroft y Gault formulae)
  • Metabolic functions: magnesium ≥ lower limit of normal (LIN)
  • Life expectancy ≥ 3 months.

Who cannot join

  • Prior malignant tumor in the last 5 years, except a history of basal cell carcinoma of the skin or pre-invasive cervical cancer.
  • Unresolved toxicities from prior systemic therapy and/or radiotherapy that, in the opinion of the investigator, does not qualify the patient for inclusion.
  • Documented or suspected central nervous system metastases.
  • Any previous antitumoral treatment (chemotherapy, hormonal therapy, radiation treatment, surgery, immunotherapy, biologic therapy) ≤ 28 days before study inclusion.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
  • Prior anti-EGFr antibody therapy (eg, Cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, Erlotinib). Subjects who discontinue their first dose of anti-EGFR therapy (Cetuximab) because of an infusion reaction may participate in this clinical trial.
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  • Paraffin-embedded tissue or unstained tumor slides from primary or metastatic tumor not available or quality ADN not available for biomarker determination by highly sensitive techniques.
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • Treatment for systemic infection within 14 days before study inclusion.
  • Acute or sub-acute intestinal occlusion and /or active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
  • History of Gilbert's syndrome or dihydropyrimidine deficiency.
  • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, and chronic active hepatitis B infection.
  • Subject allergic to the ingredients of the study medication or to Staphylococcus protein A.
  • Any co-morbid disease that would increase risk of toxicity.
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
  • Subject who is pregnant or breast feeding.
  • Surgery (excluding diagnostic biopsy or central venous catheter placement) ≤ 28 days prior study inclusion.
  • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions.
  • Subject unwilling or unable to comply with study requirements.
  • Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Digestive Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

Official title: Open Label Phase II Study of FOLFIRI + Panitumumab Using Ultra-selection Technology With Next Generation High Sensitivity Genotyping of Patients With Stage IV Colorectal Cancer Refractory to Irinotecan Without Any Mutation on KRAS, PIK3Ca, BRAF and NRAS Genes Detected With Highly Sensitive Techniques.

Open label Phase II study of FOLFIRI + Panitumumab using ultra-selection technology with next generation high sensitivity genotyping of patients with stage IV colorectal cancer refractory to irinotecan without any mutation on KRAS, PIK3Ca, BRAF and NRAS genes detected with highly sensitive techniques.

Being tested
panitumumab, FOLFIRI
Keywords
colorectal cancer, FOLFIRI, Panitumumab, KRAS, PIK3Ca,BRAF and NRAS genes, highly sensitive techniques
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panitumumabDrug

    Panitumumab 6,0 mg/kg day 1 i.v. 60 min

  • FOLFIRIDrug

    Irinotecan 180 mg/m2 day 1 i.v. 30-90 min Folinic acid 400 mg/ m2 day 1 i.v. 120 min 5-FU 400 mg/ m2 day 1 Bolus 5-FU 2.400 mg/ m2 day 1 i.v. 46 hours

Study groups in NCT01704703
Study groupRoleWhat they receive
ExperimentalExperimentalFOLFIRI + panitumumab
Receives: Drug: panitumumab; Drug: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (TRO)

    Measured: 4 years

Secondary outcomes (9)

  1. disease control rate (TCE)

    Measured: 4 years

  2. duration of response (DR)

    Measured: 4 years

  3. time to response(THR)

    Measured: 4 years

  4. time to progression (THP)

    Measured: 4 years

  5. time to treatment failure (THF)

    Measured: 4 years

  6. duration of stable disease (DEE)

    Measured: 4 years

  7. Progression free survival (SLP)

    Measured: 4 years

  8. Overall survival (SG)

    Measured: 4 years

  9. Adverse events

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01704703
Sponsor's protocol ID
TTD-12-03
Other IDs
2012-001955-38
Acronym
ULTRA
Status last verified
Jul 2017
First submitted
27 Sep 2012
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Santos C, Azuara D, Vieitez JM, Paez D, Falco E, Elez E, Lopez-Lopez C, Valladares M, Robles-Diaz L, Garcia-Alfonso P, Buges C, Duran G, Salud A, Navarro V, Capella G, Aranda E, Salazar R. Phase II study of high-sensitivity genotyping of KRAS, NRAS, BRAF and PIK3CA to ultra-select metastatic colorectal cancer patients for panitumumab plus FOLFIRI: the ULTRA trial. Ann Oncol. 2019 May 1;30(5):796-803. doi: 10.1093/annonc/mdz082.

    PubMed 30840064

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing panitumumab and FOLFIRI in people with Stage IV Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (TRO) (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01704703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.

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